UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054448 |
|---|---|
| Receipt number | R000060583 |
| Scientific Title | Placebo-controlled double-blind randomized controlled trial for verification of moisturizing effect to the patients with atopic dermatitis by Human Adipose Derived Stem Cell Conditioned Media Extract |
| Date of disclosure of the study information | 2024/05/21 |
| Last modified on | 2024/05/21 14:40:23 |
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Basic information
Public title
Verification test of moisturizer Human Adipose Derived Stem Cell Conditioned Media Extract for patients with atopic dermatitis
Acronym
Verification test of Moisturizing effect for patients with atopic dermatitis
Scientific Title
Placebo-controlled double-blind randomized controlled trial for verification of moisturizing effect to the patients with atopic dermatitis by Human Adipose Derived Stem Cell Conditioned Media Extract
Scientific Title:Acronym
Placebo-controlled double-blind randomized controlled trial for verification of moisturizing effect
Region
| Japan |
Condition
Condition
Atopic dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to confirm the moisturizing effect of continuous use of Human Adipose Derived Stem Cell Conditioned Media Extract for six weeks in subjects with atopic dermatitis and dryness symptoms on the right and left inner forearms.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Stratum corneum moisture content
Key secondary outcomes
Skin observation by a dermatologist (at screening, start date, 3 weeks after start date, and 6 weeks after start date)
- Physician's observation: dryness, desquamation, erythema, papules, scars
- Subjective symptoms: itching, irritation
Instrumental Measurement (at start date, 3 weeks after start date, and 6 weeks after start date)
- Transepidermal water loss
- Roughness, smoothness, and scale
Others (at start date, 3 weeks after start date, and 6 weeks after start date)
- Questionnaire on the usability of the subject diary and test product, etc.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Test product A is applied to the inner right forearm and test product B is applied to the inner left forearm twice daily (after waking up and bathing) for six weeks, two pushes each.
Interventions/Control_2
Test product B is applied to the inner right forearm and test product A is applied to the inner left forearm twice daily (after waking up and bathing) for six weeks, two pushes each.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
Select those who meet all of the following conditions:
- Women who are over 20 years old and not more than 60 years old.
- Those with mild symptoms of atopic dermatitis (mild skin rash such as mild erythema, dry, and desquamate lesions of any size).
- Those who have dryness and redness on the inner side of the right and left forearms.
- Those who have indicated their willingness to participate in the study and who can consent to participate in the study after understanding the explanations.
Key exclusion criteria
Exclude those who meet at least one of the following conditions:
(1) Patients with atopic dermatitis of moderate severity or higher (skin rash with severe inflammation such as lesions with erythema, papule, erosion, infiltration, lichenization, etc.) covering less than 10% of body surface area).
(2) Patients taking oral steroids, antihistamines, antiallergic agents, immunosuppressive agents, or tranquilizers.
(3) Patients who have had serious allergic symptoms due to the use of topical medicines, cosmetics, quasi-drugs, or other products in the past.
(4) Those who have a serious disease and are considered inappropriate for inclusion.
(5) Those who are under treatment or being outpatients due to illness (excluding the common cold and dental disease).
(6) Those who have a family member who works for a pharmaceutical or cosmetics company.
(7) Those who are participating or have participated within four weeks in other clinical trials or investigations involving the use of cosmetics, quasi-drugs, or food products.
(8) Any other person who is judged to be inappropriate by the investigator.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Yoshimura |
Organization
TeleBio Inc.
Division name
Headquarters
Zip code
105-0004
Address
Shimbashi Ekimae Bldg.1st #601, 2-20-15 Shimbashi, Minato-ku, Tokyo, 105-0004, Japan
TEL
+81-3-6427-9074
yoshimura@tele-bio.co.jp
Public contact
Name of contact person
| 1st name | Shohei |
| Middle name | |
| Last name | Horie |
Organization
TeleBio Inc.
Division name
Manufacturing Division
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan
TEL
+81-285-35-1489
Homepage URL
s.horie@tele-bio.co.jp
Sponsor or person
Institute
TeleBio Inc.
Institute
Department
Personal name
Funding Source
Organization
TeleBio Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
General Incorporated Association Clinical Research Review Center
Address
2972-8-603 Ishikawamachi, Hachioji-shi,Tokyo,192-0032, Japan
Tel
+81-90-3547-6398
crrctakashima@kpd.biglobe.ne.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
株式会社インフォワード 恵比寿スキンリサーチセンター（東京都）
Ebisu Skin Research Center, Inforward, inc.(Tokyo)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
28
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 21 | Day |
Last modified on
| 2024 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060583
